The FDA has granted orphan drug designation to the oral agent OPN-6602 for the treatment of patients with relapsed or ...
Researchers sought to determine whether teclistamab would lead to a clinical response in patients with relapsed/refractory multiple myeloma.
The FDA has accepted the resubmitted biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma in heavily pretreated adults. The FDA has accepted the resubmitted ...
Linvoseltamab is an investigational B-cell maturation antigen CD3-targeted bispecific antibody. The BLA resubmission was needed as the original application could not be approved due to manufacturing ...
Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: REGN) today announced ...
The off-the-shelf chimeric antigen receptor T-cell therapy P-BCMA-ALLO1 was shown to be safe and elicited strong anti-tumor ...
The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma ...
an investigational treatment for adult patients with relapsed/refractory multiple myeloma. This acceptance follows the resolution of previously identified third-party fill/finish manufacturing issues.
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